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Advanced understanding of Staphylococcus aureus and Pseudomonas aeruginosa Infections in EuRopE * Intensive Care Units (ICU)

Completed
Conditions
lower respiratory tract infection
lung infection
10004018
10024970
Registration Number
NL-OMON43881
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

1. Participant is 18 years or older at the time of enrollment.
2. Participant is on mechanical ventilation at ICU admission, or is (expected to be) within 24 hours thereafter, based on investigator*s judgment.
3. Expected stay in ICU is 48 hours or longer based on investigator*s judgment.
4. SA colonization status is known within 72 hours after start of first episode of mechanical ventilation ICU admission and according to the result the patient qualifies for enrollment (see section 4.1).
5. Written informed consent from subject / legally accepted representative within 72 hours after start of first episode of mechanical ventilation.

Exclusion Criteria

1. Previous participation as a subject in the study cohort of this study.
2. Simultaneous participation of the subject in any preventive experimental study into anti-staphylococcus or anti-pseudomonas aeruginosa interventions.
3. Expected death (moribund status) within 48h or ICU discharge of the participant within 24h, at the moment of informed consent.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcomes are the incidence of S. aureus ICU acquired pneumonia and<br /><br>the incidence of P. aeruginosa ICU acquired pneumonia through ICU stay. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- colonization with S. aureus at ICU admission<br /><br>- colonization with P. aeruginosa at ICU admission<br /><br>- mortality through day-90 post ICU admission<br /><br>- time to primary outcomes in days</p><br>
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